A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers

NCT01537497 | Completed Phase 1

• 1 other identifier: B1731013
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion in healthy volunteers

Conditions

Diabetes Mellitus, Type 2

Keywords

Phase 1; Single Doses; Pharmacodynamics; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Modulation of carbohydrate and lipid metabolism

  24 hours

Secondary Outcomes (3)

• Cmax of PF-05175157 after single oral doses

  24 hours

• Tmax of PF-05175157 after single oral doses

  24 hours

• Area under the curve (AUC) of PF-05175157 after single oral doses

  24 hours

Study Arms (4)

100 mg PF-05175157

EXPERIMENTAL

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Drug: PF-05175157

250 mg PF-05175157

EXPERIMENTAL

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Drug: PF-05175157

600 mg PF-05175157

EXPERIMENTAL

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Drug: PF-05175157

Placebo

PLACEBO COMPARATOR

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Drug: Placebo

Interventions

PF-05175157 DRUG

One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.

100 mg PF-05175157

Placebo DRUG

One single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
• Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. In addition, subjects must have normal pulmonary function tests and normal ocular findings.
• Women must be of non-childbearing potential.
• Body Mass Index (BMI) of 19.5 35.5 kg/m2, and a total body weight of \> 50 kg (110 lbs).

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
• Evidence or history of any chronic ongoing or current pulmonary disease.
• History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day -7.
• Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: February 23, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

US (1)